N/A
Completed N=154
Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients
Source: ClinicalTrials.gov NCT01588106 ↗Enrolled (actual)
154
Serious AEs
0.7%
Results posted
Mar 2017
Primary outcomePrimary: Reduction in HbA1c — -0.52; -0.14 % (unit of HbA1c)
Summary
The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in HbA1c as primary endpoint.
Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be trained in using the devices and return every 3 months until month 9 after baseline.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in HbA1c |
-0.52; -0.14 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Therapy with insulin only (ICT) or ICT in combination with Metformin
- HbA1c at baseline > 7.5% and 40 kg/m²
- Anemia according to WHO-definition (hemoglobin 150 µmol/l and/or GFR < 50 mmol/min/ 1.73m² (measured within the last 3 months before screening)
- Operation with inpatient stay planned during the study
- Current pregnancy or pregnancy planned during the study; or breastfeeding women.
- Women with childbearing potential who are not practicing an acceptable method of birth control. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomized partner
- Alcohol or drug abuse within the last 3 months
- Patients with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
- Significant visual impairment
- Significant hearing impairment
- Cognitive disorder
- Significant unstable co-morbidity (with notable change within the past 3 months)
- Severe renal disease, disease with a strong impact on life expectancy
- Inability to have or use and computer
- Inability to use a meter correctly
- Any other condition as per investigator's discretion
- Current participation in another clinical study. Participation in another trial within 6 weeks before screening.
- Employees of Bayer Vital Diabetes Care, the GWT or the University of Dresden
Data sourced from ClinicalTrials.gov (NCT01588106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.